The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Micro Organism Growth Sys-m1000.
Device ID | K843000 |
510k Number | K843000 |
Device Name: | MICRO ORGANISM GROWTH SYS-M1000 |
Classification | Device, Specimen Collection |
Applicant | HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill , NJ 08034 - |
Contact | Julius J Jablonsky |
Correspondent | Julius J Jablonsky HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill , NJ 08034 - |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-30 |
Decision Date | 1985-02-06 |